A wide variety of tubes or ‘tube-like’ devices are utilized in common medical procedures. For example, tubes can be utilized to: 1) bypass an obstruction (e.g., in the case of Coronary Artery Bypass Grafts, or “CABG” or peripheral bypass grafts) or open up an obstruction (balloon dilation catheters, angioplasty balloons); 2) to relieve pressure or obstructions (e.g., shunts, drainage tubes and drainage catheters); 3) to restore or support anatomical structures (e.g., endotracheal tubes, tracheostomy tubes, urinary catheters and feeding tubes); and 4) for vascular access (e.g., CVC catheters and hemodialysis catheters). However, such tubes are susceptible to a wide variety of complications, including for example, infection and blockage.
One example of commonly used medical tubes are catheters. Catheters are thin tubes that are commonly used for a wide variety of medical conditions, and in a wide variety of medical procedures. Typically, they are inserted into a body cavity, lumen, duct, or vessel, which may be naturally occurring (e.g., a blood vessel, urinary tract, gastrointestinal tract, etc.), or artificially created (e.g., by way of an accident, disease, infection, or surgical procedure). Catheters are often inserted into the body by first advancing a flexible, metallic guidewire into the desired anatomical location; the catheter is then placed over the guidewire and maneuvered into its final position. In this manner they can, depending on the indication or procedure, allow for drainage (bile, urine, pus, serous fluids, etc.), administration of fluids (e.g., saline solutions, drugs, etc.), provide access for medical and surgical procedures (peritoneal dialysis, hemodialysis, etc.), provide access for various medical or surgical instruments, and/or of themselves be utilized to perform a wide variety of surgical procedures.
Catheters can be composed of a wide variety of materials (including for example metal such as nitinol), although most are made from polymers. Typical polymers that are used in the construction of catheters include silicone, nylon, polyurethane, and polyethylene terephthalate. Catheters may be composed of biodegradable or erodible polymers, non-biodegradable polymers, or some combination of these. Guidewires can be composed of a variety of materials but are typically made of metals such as stainless steel, nitinol, titanium or some combination of these.
Representative examples of common catheters are provided in FIG. 1. FIG. 1A illustrates a variety of representative Foley catheters, which are used to allow drainage of the urinary bladder. FIG. 1B depicts several representative balloon catheters of different sizes that show expansion of the balloon portion of the catheter. FIG. 1C illustrates a variety of different balloon catheters. FIG. 1D illustrates a ureteral catheter.
Unfortunately, when a guidewire and/or a catheter is inserted, various complications may arise during the procedure (whether surgical, or non-surgical procedures such as the placement of a urinary catheter) or after the catheter has been implanted. For example, during a surgical procedure, the surgeon may wish to confirm correct anatomical placement and alignment of the guidewire and then the correct anatomical placement and alignment of the catheter and/or any motion/movement between the catheter and the surrounding tissue so that adjustments can be made during the procedure. In addition, to the extent the catheter is utilized in a surgical procedure to deliver another medical device, a physician may wish to confirm the correct placement and/or deployment of a device (such as a stent), or the delivery a desired medical device to its desired anatomical location. Post-procedure, the patient may experience inflammation and pain if there is slight movement of the catheter, the catheter can potentially migrate from the placement site and cease to be effective, the lumen of the catheter can become obstructed by blood clots, “stones” (urinary or biliary), foreign bodies or other tissue debris, and in some cases become infected or covered in biofilm.
The present invention discloses novel tubes (e.g., catheters, endotracheal or chest tubes, bypass grafts, balloon catheters, urinary catheters, central lines and dialysis catheters), as well as related delivery devices (e.g., guidewires) which overcome many of the difficulties of previous tube-like devices, methods for constructing and monitoring these novel devices, and further provides other related advantages.